Prescription for Change targets public clinical trials, marketing practices
in wake of Vioxx, Paxil incidents; 25,000 consumers call for public disclosure
FOR IMMEDIATE RELEASE
Wednesday, Nov. 10, 2004
Contact: Susan Herold, 202-462-6262
Rob Schneider, 914-378-2208
(Washington, D.C.) – Recognizing consumers’ frustration over skyrocketing prescription drug prices and recent safety concerns, Consumers Union is launching a national grassroots advocacy campaign – Prescription for Change – that will empower consumers to change both policy and the marketplace to ensure safe, effective and affordable prescription drugs for all.
“For far too long important decisions on price, safety and availability of prescription drugs have been an insider game played by pharmaceutical lobbyists, the drug companies and their sales reps,” said Rob Schneider, campaign director of Prescription for Change.
“The result has been unaffordable medicines, safety information hidden from public view, and a drug industry that stymies true reform,” Schneider said.
The initial effort is calling for a mandatory, public registry of drug companies’ clinical trials to ensure that drug safety and effectiveness information is readily available to researchers, physicians and consumers. More than 25,000 consumers already have sent emails via Consumers Union’s website to Congress supporting a mandatory registry, and legislation requiring public disclosure of drug trials has been introduced in both the House and Senate.
Recently the makers of two popular drugs – Vioxx and Paxil – have faced intense scrutiny for downplaying negative safety information in their clinical trials. The Food and Drug Administration (FDA), which is responsible for drug safety, also has come under fire for responding slowly to safety concerns raised by these drug trials.
By requiring all drug trial information to be registered and made public, potential safety risks could be more quickly identified, Schneider said. Currently, drug companies must submit their clinical trial information to the FDA, but none of that information is required to be made public.
“We are constantly bombarded by advertisements and marketing from drug companies telling us to buy their newest, most expensive drug,” Schneider said. “But who is making sure patients and doctors are hearing the other side of the story about safety and effectiveness?
“If all drug studies are registered and made available to physicians, researchers, and the public,” he added, “there will be increased scrutiny, resulting in drug makers and the FDA responding quickly to safety concerns.”
Earlier this year it was reported that a clinical trial study found that teenagers who took the antidepressant Paxil were more likely to consider suicide, but the maker of the drug, GlaxoSmithKline, never released the negative information to the public. In September, the painkiller Vioxx was pulled from the market after it was linked to increased heart attack risk, yet the media has reported drug maker Merck may have known about the risk for years.
Prescription for Change is unique in that it will give consumers the information and tools to make their voices heard at both the state and federal level to counter the overwhelming number of well-financed pharmaceutical lobbyists who now dominate the prescription drug debate. The Prescription for Change web site allows consumers to send messages directly to their state and national legislators demanding change.
“The time has come for consumers to participate in these decisions in a meaningful way, and we intend to give them the tools and information to do that,” Schneider added.
Prescription for Change also will enlist consumers in its effort to require drug companies to report the gifts and marketing dollars they lavish on doctors to prescribe their brand-name drugs; harness the state and federal government’s ability to negotiate lower prices by using their bulk purchasing power; and ensure drug pricing and effectiveness information is readily available to all consumers.
Prescription for Change is one of several health projects being launched by Consumers Union, the independent, nonprofit publisher of Consumer Reports, to help consumers get credible, trustworthy information to make informed decisions about their healthcare.
For more information on the current effort to require a clinical drug trial registry, go to http://www.consumersunion.org/campaigns/prescription/learn.html
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